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Lupin receives approval for Rufinamide oral suspension
Lupin receives approval for Rufinamide oral suspension
Pharma major, Lupin Limited on Monday said it has received approval from the US health regulator to market a generic drug used in the treatment of seizures associated with Lennox-Gastaut syndrome.
Pharma major, Lupin Limited on Monday said it has received approval from the US health regulator to market a generic drug used in the treatment of seizures associated with Lennox-Gastaut syndrome. It has received approval from the US Food and Drug Administration (USFDA)for its Rufinamide Oral Suspension in 40Â mg/ml strength.
In a regulatory filing, the company said, Lupin Limited, a global pharmaceutical company, has received approval for its Rufinamide Oral Suspension, 40 mg/ml, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Banzel® Oral Suspension, 40 mg/ml, of Eisai Inc."
The drug maker's product is the generic equivalent of Eisai Inc's Banzel oral suspension.
Rufinamide Oral Suspension, 40 mg/ml is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in pediatric patients 1 year of age and older, and in adults.
As per IQVIA MAT September 2020 data, Rufinamide Oral Suspension, 40 mg/ ml (RLD: Banzel®) had estimated annual sales of USD 124.5 million in the US.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the US, India, South Africa and across the Asia Pacific {APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system {CNS) and women's health areas.
Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions and fifth in India by global revenues. The company invests 9.6 per cent of its revenues on research and development.
